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Generated: May 23, 2017

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Details for New Drug Application (NDA): 200327

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NDA 200327 describes TEFLARO, which is a drug marketed by Cerexa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEFLARO profile page.

The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.

Summary for NDA: 200327


Pharmacology for NDA: 200327


Suppliers and Packaging for NDA: 200327

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ceftaroline fosamil
POWDER;IV (INFUSION) 200327 NDA Forest Laboratories, Inc. 0456-0400 0456-0400-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)
ceftaroline fosamil
POWDER;IV (INFUSION) 200327 NDA Forest Laboratories, Inc. 0456-0600 0456-0600-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength400MG/VIAL
Approval Date:Oct 29, 2010TE:RLD:Yes
Patent:6,906,055Patent Expiration:Dec 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,419,973Patent Expiration:Dec 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,247,400Patent Expiration:Feb 10, 2031Product Flag?YSubstance Flag?Delist Request?

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